A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04539548 |
Recruitment Status :
Recruiting
First Posted : September 7, 2020
Last Update Posted : January 28, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataract | Drug: Dextenza Drug: Prednisolone | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Parallel-Arm, Active Control, Multi-Center Study Assessing the Safety And Efficacy Of Dextenza® for the Treatment Of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract |
Actual Study Start Date : | September 4, 2020 |
Estimated Primary Completion Date : | August 30, 2022 |
Estimated Study Completion Date : | October 30, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Dextenza
1 dosing group - Approximately 30 subjects treated with Dextenza
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Drug: Dextenza
Dextenza, dexamethasone ophthalmic insert |
Active Comparator: Prednisolone
1 dosing group - Approximately 30 subjects treated with Prednisolone
|
Drug: Prednisolone
Prednisolone, acetate ophthalmic suspension |
- Absence of pain [ Time Frame: 8 days post treatment ]FLACC score of '0' (Face, Legs, Activity, Cry, Consolability)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 3 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pediatric cataract diagnosis
- Subject is >0 - 3 years of age
Exclusion Criteria:
- Any intraocular inflammation in the study eye
- Ocular hypertension or glaucoma
- Evidence of acute external ocular infections

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539548
Contact: Clinical Project Manager | 781-357-4000 | clinicalaffairs@ocutx.com |
United States, Colorado | |
Ocular Therapeutix | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Clinical Project Manager | |
Ocular Therapeutix | Recruiting |
Fort Collins, Colorado, United States, 80525 | |
Contact: Clinical Project Manager | |
United States, Florida | |
Ocular Therapeutix | Recruiting |
Jacksonville, Florida, United States, 32202 | |
Contact: Clinical Project Manager | |
United States, Indiana | |
Ocular Therapeutix | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Clinical Project Manager | |
United States, Kentucky | |
Ocular Therapeutix | Recruiting |
Lexington, Kentucky, United States, 40508 | |
Contact: Clinical Project Manager | |
United States, Massachusetts | |
Ocular Therapeutix | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Clinical Project Manager | |
United States, Minnesota | |
Ocular Therapeutix | Recruiting |
Minneapolis, Minnesota, United States, 55454 | |
Contact: Clinical Project Manager | |
Ocular Therapeutix | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Project Manager | |
United States, Missouri | |
Ocular Therapeutix | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Clinical Project Manager | |
United States, Pennsylvania | |
Ocular Therapeutix | Recruiting |
Erie, Pennsylvania, United States, 16501 | |
Contact: Clinical Project Manager | |
United States, South Carolina | |
Ocular Therapeutix | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Clinical Project Manager | |
United States, Tennessee | |
Ocular Therapeutix | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Clinical Project Manager | |
United States, Virginia | |
Ocular Therapeutix | Recruiting |
Virginia Beach, Virginia, United States, 23452 | |
Contact: Clinical Project Manager | |
United States, Wisconsin | |
Ocular Therapeutix | Recruiting |
Madison, Wisconsin, United States, 53705 | |
Contact: Clinical Project Manager |
Responsible Party: | Ocular Therapeutix, Inc. |
ClinicalTrials.gov Identifier: | NCT04539548 |
Other Study ID Numbers: |
CLN-Protocol-0050 |
First Posted: | September 7, 2020 Key Record Dates |
Last Update Posted: | January 28, 2022 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Dextenza, dexamethasone ophthalmic insert |
Cataract Inflammation Pathologic Processes Lens Diseases Eye Diseases Prednisolone Anti-Inflammatory Agents |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |